Clinical trial

Nutritional Therapy to Incretin-based Anti-obesity Medications in the Management of Gastrointestinal Adverse Events

Recruiting now · Not applicable · 1 countries · Registry ID NCT06431308

Recruiting nowNot applicableInterventional

What this study is about

The goal of the study is to evaluate the effect of nutrition intervention on gastrointestinal symptoms, treatment discontinuation rate, nutritional parameters (e.g., dietary intake and eating habits), anthropometric measures, functional parameters, and QOL during the initiation and up-titration phase of incretin-based Anti Obesity Medications (AOM) treatment in patients with overweight/obesity. The nutrition intervention protocol will be developed based on literature review, focus groups with health care professionals, and patient interviews. A single-center pilot study will be performed at the Tel-Aviv Assuta Medical Center, among 10 patients who are about to initiate long-term weight management treatment with Wegovy© (semaglutide 2.4 mg), followed by a multi-center, parallel design open-label, RCT, which will be conducted at the Tel-Aviv Assuta Medical Center and Rabin Medical Center - Beilinson Hospital, in 120 patients who are about to initiate long-term weight management treatment with Wegovy© or Mounjaro© . The intervention group will receive nutrition guidance before AOM treatment by registered dietitian (RD) followed by nutrition and behavioral recommendations according to reported gastrointestinal symptom(s). The control group will receive the usual nutrition care for patients treated with AOM. Primary outcomes (gastrointestinal symptom assessment) and secondary outcomes (incretin-based AOM discontinuation rate, nutritional parameters, anthropometrics, functional parameters and QOL) will be evaluated by interviews, questionnaires and measurements at baseline, at the end of Wegovy© or Mounjaro© titration phase \[20 weeks (T1)\] and weekly during the study period (for GI symptoms assessment).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersAccepted

ConditionObesity; Drug

Full registry criteria

Inclusion Criteria: * individuals aged ≥ 18 years * eligible to receive AOM \[i.e., BMI ≥ 30 kg/m2 or ≥ 27 kg/m2 with at least one adiposity-related coexisting condition (e.g., diabetes or pre-diabetes, hypertension, dyslipidemia, obstructive sleep apnea, fatty liver, cardiovascular disease)\] * who can read and speak Hebrew. Exclusion Criteria: * Contraindications or precautious for treatment with Wegovy© or Mounjaro© \[i.e., personal or family history of medullary thyroid cancer (MTC), personal history of multiple endocrine neoplasia type 2 (MEN2) syndrome, attempting conception, current pregnancy or breastfeeding\] * previous bariatric surgery or endo-bariatric procedure * presence of chronic pancreatitis * treatment with AOM within a month before enrollment * patients with type 1 diabetes mellitus * patients who underwent other major GI surgery prior to medication treatment * patient with underlying GI disease \[e.g., gastroparesis, celiac, Inflammatory Bowel Disease (IBD)\] * a positive diagnosis of small-intestinal bacterial overgrowth (SIBO) * patients with active gastritis, gastroenteritis * chronic usage of promotility drugs or laxatives * patients with uncontrolled mental illness * significant cognitive deterioration * alcohol consumption exceeding 1 drink per day for women and 2 drinks per day for men . In addition, participants who decide not to initiate or stop Wegovy© or Mounjaro© treatment for more than two consecutive injections for any reason or who undergo bariatric surgery or endoscopic sleeve gastroplasty during the study period will be excluded from the study

Treatments and study arms

nutritional intervention

Behavioral

A nutrition guidance before initiation of AOM treatment include recommendations for food choices and eating habits to minimize the occurrence and severity of GI symptoms during the up-titration phase, will be given by registered dietitian (RD) from the study team. Next, each week, participants will provide weekly reports of GI symptoms occurrence and severity, by responding to queries sent via WhatsApp/SMS and for occurring symptoms, an automatically structured nutrition and behavioral treatment recommendations will be sent . If participants expressed an interest in personalized dietary guidance on this matter, the study team RD will contact him/her by telephone, within a range of 48 hours, to provide individualized recommendations. Three days after each report of GI symptom(s), participants will receive an additional message and will be asked to report the occurrence and severity of the GI symptom, and their compliance with the specific dietary instructions received.

Primary outcomes

Gastrointestinal symptoms assessmentBaseline and at the end of the study period (20 weeks)

GI symptoms rating scale (GSRS) - assess the degree of specific GI complaints Every question is rated by seven graded Likert-type scale (1 represents the absence of troublesome symptoms and 7 represents very troublesome symptoms) while a higher score of the whole questionnaire and by dimension represents more severe symptoms.

Defecation textureBaseline and at the end of the study period (20 weeks)

Bristol stool scale - classifying the form of human feces into seven categories. Type 1-2 are considered abnormal hard stools and indicative of constipation type, and type 5-7 are considered abnormally loose/liquid stools and indicative of diarrhea or urgency

Bowel Movement (BM) frequencyBaseline and at the end of the study period (20 weeks)

will be assessed according to five acceptable categories: \>3 BMs/day, 2-3 BMs/day, 1-2 BMs/day, 3-4 BMs/week, \<3 BMs/week

Participants gastrointestinal symptoms reportBaseline, at the end of the study period (20 weeks) and weekly until 20 weeks (for subjective GI symptoms report only)

Participant subjective and objective reporting of GI symptoms